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Lilly’s Oral GLP-1 Pill Clears Late-Stage Test in Diabetes and Obesity, Paving Way for Global Filings

Lilly says the study completes the data needed to begin worldwide submissions for a once-daily small‑molecule pill that targets GLP‑1.

Eli Lilly Biotechnology Center is shown in San Diego, California, U.S. March 1, 2023. REUTERS/Mike Blake/File Photo
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Overview

  • In the 72‑week ATTAIN‑2 trial of more than 1,600 adults with obesity plus type 2 diabetes, the highest dose of orforglipron produced 10.5% average weight loss versus 2.2% with placebo, with 9.6% when analyzing all randomized patients.
  • Glycemic control improved as A1C fell by 1.3% to 1.8% across doses, and 75% on the top dose reached an A1C of 6.5% or lower; cardiovascular risk markers, including cholesterol, triglycerides and blood pressure, also improved.
  • Gastrointestinal side effects were common and generally mild to moderate, with nausea in 36.4%, vomiting in 23.1% and diarrhea in 27.4% at the highest dose; about 10% discontinued for side effects and roughly 20% stopped for any reason, similar to placebo.
  • Lilly said the results give it a complete clinical package to initiate global regulatory submissions for chronic weight management, noting that orforglipron is a once‑daily small‑molecule pill without fasting or water restrictions.
  • The pill enters a competitive race with Novo Nordisk, whose oral Wegovy application is under FDA review with a decision expected by year‑end, as investors sent Lilly shares up about 4% following the announcement; findings were released via company statements and are pending peer review.